Treatment for Post Acute COVID-19 Syndrome
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 22, 2022
August 1, 2022
8 months
August 17, 2022
August 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Tinnitus Handicap Inventory (THI)
The Tinnitus Handicap Inventory Scale is between 0-100. And is stratified to Grades between 1-5. A higher grades means more severe handicap from tinnitus.
4 weeks
Study Arms (2)
Dopamine Receptor Modulator
EXPERIMENTALPimozide 1mg Oral
Placebo
PLACEBO COMPARATORPlacebo Oral
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with subjective tinnitus post COVID-19
- Tinnitus persists for at least 4 weeks
- Prior history of mild or no tinnitus
- years or older
- Any gender
- Females of child bearing age must be on contraception
You may not qualify if:
- Pregnant
- Patients who participated in any interventional studies in the past 6 months
- Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
- Patients taking any dopamine receptor antagonists
- Patient having history of hypersensitivity to Pimozide
- Patients unable to comply with the study schedule
- Actively using cortiocosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Applied Biology, Inc.lead
- Jupiter Wellness, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
RAHUL RAJENDRA KUNKULOL, MBBS
DEPT.OF PHARMACOLOGY, RURAL MEDICAL COLLEGE, PIMS- DU (DU), LONI, PIN: 413736
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 19, 2022
Study Start
October 1, 2022
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share